—#137918

Product

ARCHITECT c8000 System List Number 01G06-98 Product Usage: The Abbott ARCHITECT cSystem is intended for In Vitro diagnostic use only. It is designed to perform automated: chemistry tests, utilizing photometry and potentiometric technology.

FDA product code: JJE — Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Device class: Class 1
Medical specialty: Clinical Chemistry
510(k) numbers: K980367
Affected lot / code info: Serial Numbers: C802239, C802312, C802260, C802447, C801911

Why it was recalled

The ARCHITECT c8000 instrument contains tubing that does not meet specifications and has the potential to leak.

Root cause (FDA determination)

Mixed-up of materials/components

Action the firm took

Abbott notified thier affected consignees via phone or visit on 5/29/15. A follow up Product Recall notification letter dated June 4, 2015 was sent to affected customers. The letter identified the affected product, problem and actions to be taken. The letter instructed customers to immediately discontinue use of the product, Abbott representative will be make all necessary arrangements for replacing your impacted instruments(s), follow your laboratory protocol regarding the need to review previously reported patient results and retain this notification for laboratory records. For questions contact Customer Service at 1-877-4ABBOTT.

Recalling firm

Firm: Abbott Laboratories
Address: 100 Abbott Park Rd, Abbott Park, Illinois 60064-3502

Distribution

Distribution pattern: US Nationwide Distribution in the states of CA, AL, NY and WI.

Timeline

Recall initiated: 2015-06-11
Posted by FDA: 2015-07-22
Terminated: 2016-02-09
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #137918. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.